The Munich Regional Court granted Halozyme a preliminary injunction on December 4, 2025 that bars Merck from distributing its Keytruda SC subcutaneous formulation in Germany. The court found that Merck’s product infringes Halozyme’s MDASE patent, European Patent No. 2 797 622 (EP 622).
The injunction protects Halozyme’s subcutaneous delivery technology, a core element of its ENHANZE platform, and limits competition in a key European market. Halozyme’s legal team emphasized that the MDASE patents are distinct from its ENHANZE licensing program, so existing licensing relationships remain unaffected. The ruling also signals the strength of Halozyme’s intellectual‑property portfolio and supports its strategy to defend its subcutaneous delivery technology worldwide.
Halozyme has recently reported strong Q3 2025 results, with revenue growth that prompted the company to raise its full‑year 2025 revenue guidance to $4.396‑$4.400 billion from $4.14‑$4.15 billion. The company also increased its adjusted EBITDA guidance, reflecting confidence in continued margin expansion driven by high‑margin royalty streams and expanding ENHANZE licensing deals. Management highlighted that the injunction is a positive development for the company’s IP strategy and will help safeguard future revenue streams from its subcutaneous delivery technology.
Merck has strongly disagreed with the ruling, calling the patent invalid and the infringement claim without merit. The company has also initiated nullity proceedings against the patent in the German Federal Patent Court and continues to contest the injunction. Despite the legal dispute, patients in Germany will still have access to the intravenous version of Keytruda, which is not covered by the injunction.
Analysts have offered mixed commentary. Citizens noted the injunction as a compelling upside driver for Halozyme’s IP portfolio, while Goldman Sachs maintained a “sell” rating, citing valuation concerns. The market reaction reflects the balance between the positive impact of the injunction on Halozyme’s competitive position and the broader valuation dynamics in the biopharmaceutical sector.
Halozyme’s global enforcement strategy is reinforced by the German ruling, which complements its U.S. lawsuit in the New Jersey federal district court alleging infringement of 15 patents. The injunction strengthens Halozyme’s position in the subcutaneous delivery space and supports its long‑term growth strategy, while Merck’s continued legal challenges underscore the ongoing competitive and regulatory dynamics in the oncology drug market.
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